• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

+39 06 9053 0130

  • Youtube
  • Twitter
  • Linkedin
  • Italiano
    • 中文
    • 台灣
    • Singapore
    • Denmark
    • English
    • English / CH
    • Français
    • Français / CH
    • Deutsch
    • Deutsch / CH
    • Deutsch / AT
    • 日本語
    • 한국어
    • Português
    • Español
Newsletter

Search

  • Linkedin
  • Twitter
Particle Measuring Systems
Without measurement there is no control
Richiedi un preventivo
  • Home
  • Prodotti
    • Contatori di Particelle per Aria
    • Contatori di Particelle per Liquidi
    • Campionatori Microbiologici
      • BioCapt®Certificates of Analysis
    • Monitoraggio della Contaminazione nei Gas Compressi
    • Monitoraggio Molecolare
    • Software / Data Management
  • Formazione
    • Virtual Particle Days 2020
    • Knowledge Center
      • Application Notes
      • Guida Base al Conteggio Particellare
      • Video
      • Webinar – Archivio
    • Servizi di Training e Consulenza
    • Blog
  • Applicazioni
    • Industrie
      • Life Sciences/Farmaceutico
      • Semiconduttori
      • Fotonica e Ottica
      • Aerospaziale e Difesa
      • ISO 22716 Soluzioni per la Cosmetica e l’Igiene Personale
    • ISO 14644
    • ISO 21501-4
    • USP 788
    • USP 797
    • Annex 1 Ultimi Aggiornamenti
    • 21CFR 11
  • Servizi e Supporto
    • Servizi di Project Management del Sistema di Monitoraggio
    • Servizi di GMP
      • Misurazione
      • Smoke Test
      • Convalide Termiche
    • Servizio Calibrazione e Riparazione
    • Servizio Clienti
    • Servizi di Advisory
  • Chi siamo
    • Contattaci
    • Perché PMS
    • Management
    • Lavora con noi
    • Responsabilità Aziendale
    • COBE
    • Casa Madre
    • Comunicati Stampa
    • Qualità e Riconoscimenti
    • Marchi e Brevetti
Blog
Aprile 29, 2020 03:19 PM

Quality Risk Management in Annex 1; 6.1

Written by PMS

The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in all aspects of sterile product manufacturing. In part 2 of our five part series, we highlight requirements related to Quality Risk Management that are specifically mentioned in Annex 1, section 6.1 around utility systems:

“The nature and extent of controls applied to utility systems should be commensurate with the risk to product quality associated with the utility. The impact should be determined via a risk assessment documented as part of the CCS.”

This applies to critical product contact utilities such as:

  • purified water
  • WFE
  • clean steam
  • any other gases that have direct product contact

It is necessary to conduct a scientific evaluation of the characteristics and functionality of each point; the goal is to define QC sampling points and Points of Use. It is important to make sure to consider any unused points and that an evaluation of each valve regarding slope, positioning and disinfection is done. Other items to consider are how the piping is managed: flushing, disinfecting, etc.

This will also help determine the appropriate sampling handling technique and what are the appropriate sample containers to develop a sampling plan.

Benefits of using QRM for Utilities Monitoring

A sampling program should include:

  • All points of use, at a specified interval, to ensure that representative water samples are obtained for analysis on a regular basis.
  • The RA helps us defines sampling points by different criticality; e.g.: WFI for RM versus WFI for cleaning.
  • Establish different frequencies based on the risk
  • This helps to reduce time and material to do the testing
  • Help ensure sampling is done at areas that are at the greatest risk to products

Quality Risk Management Annex 1

Learn how our Advisory Services Team can help you conduct a Risk Assessment.

In the next blog in this series we will continue to examine Annex 1 and QRM principles and areas where those are discussed.

Want to read more? Jump to other released posts in this series:

  • Part 1 of 5, published April 23: Quality Risk Management- Principle Section 2
  • Part 2 of 5, Quality Risk Management- Annex 1 section 6.1 (you are here!)
  • Part 3 of 5, publishing April 28 V/NV Environmental and Process Monitoring- Annex 1, Section 9.4
  • Part 4 of ,5 publishing April 30 Definition of potential sampling points
  • Part 5 of 5, publishing May 1; Blog 5 Process Risk Assessment

 See links to additional supporting resources below: 

  • Paper: Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom
  • On-Demand Webinar: Case Study: Developing an Isolator Filling Line using a Quality Risk Management Approach
  • Blog series: How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)

Don’t miss an episode of this series. Register for updates on the right column of this page. Click here to contact our Experts for questions.

 

Filed Under: Quality Risk Management Tagged With: annex 1, microbial monitoring, particle counters

Archives

  • Agosto 2020 (1)
  • Luglio 2020 (3)
  • Giugno 2020 (2)
  • Maggio 2020 (4)
  • Aprile 2020 (7)
  • Marzo 2020 (1)
  • Novembre 2019 (1)
  • Settembre 2019 (1)
  • Giugno 2019 (1)
  • Maggio 2019 (1)
  • Febbraio 2019 (1)
  • Ottobre 2018 (1)
  • Ottobre 2017 (1)
  • Marzo 2016 (2)

Iscriviti alla nostra newsletter

Prodotti

  • Contatori di Particelle per Aria
  • Contatori di Particelle per Liquidi
  • Campionatori Microbiologici
  • BioCapt®Certificates of Analysis
  • Contatori di Particelle per Gas Compressi
  • Monitoraggio Molecolare
  • Software / Data Management

Industrie

  • Life Sciences/Farmaceutico
  • Semiconduttori
  • Fotonica e Ottica
  • Aerospaziale e Difesa
  • Produzione Industriale

Servizi e Supporto

  • Servizi di Advisory
  • Servizi di Misurazione GMP
  • Servizio Calibrazione e Riparazione
  • Smoke Test GMP
  • Servizi di Convalide Termiche GMP
  • Servizio Clienti

Knowledge Center

  • Application Notes
  • Video
  • Blog

CHI SIAMO

  • Contattaci
  • Perché PMS
  • Management
  • Lavora con noi
  • Responsabilità Aziendale
  • COBE
  • Casa Madre
  • Comunicati Stampa
  • Qualità e Riconoscimenti
  • Marchi e Brevetti

Particle Measuring Systems- IT

Particle Measuring Systems Srl
Via di Grotte Portella, 34
00044 Frascati (Roma)

T. +39-06-90530130
F. +39-06-9051315
[email protected]
P.I. 10427421002

Ricevi i nostri aggiornamenti:

Prodotti

  • Contatori di Particelle per Aria
  • Contatori di Particelle per Liquidi
  • Campionatori Microbiologici
  • BioCapt®Certificates of Analysis
  • Contatori di Particelle per Gas Compressi
  • Monitoraggio Molecolare
  • Software / Data Management

Industrie

  • Life Sciences/Farmaceutico
  • Semiconduttori
  • Fotonica e Ottica
  • Aerospaziale e Difesa
  • Produzione Industriale

Applicazioni

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Annex 1 Ultimi Aggiornamenti
  • 21CFR 11

Servizi e Supporto

  • Servizi di Advisory
  • Servizi di Misurazione GMP
  • Servizio Calibrazione e Riparazione
  • Smoke Test GMP
  • Servizi di Convalide Termiche GMP
  • Servizio Clienti

Formazione

  • Knowledge Center
    • Particle Days 2019
  • Servizi di Training e Consulenza
  • Blog

CHI SIAMO

  • Contattaci
  • Perché PMS
  • Management
  • Lavora con noi
  • Responsabilità Aziendale
  • COBE
  • Casa Madre
  • Comunicati Stampa
  • Qualità e Riconoscimenti
  • Marchi e Brevetti

Particle Measuring Systems- IT

Particle Measuring Systems Srl
Via di Grotte Portella, 34
00044 Frascati (Roma)

T. +39-06-90530130
F. +39-06-9051315
[email protected]
P.I. 10427421002

Ricevi i nostri aggiornamenti:

  • Privacy Policy
  • Note Legali
  • Marchi e brevetti
  • Accreditamenti e riconoscimenti

© Copyright 2021 - Particle Measuring Systems is a Spectris company